Diabetes Telemedicine Consultation: A Systems Improvement Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119041
First received: July 1, 2005
Last updated: May 18, 2015
Last verified: May 2015

July 1, 2005
May 18, 2015
September 2005
December 2007   (final data collection date for primary outcome measure)
A1c [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]
Hemoglobin A1c is a measure of glycemic control
Not Provided
Complete list of historical versions of study NCT00119041 on ClinicalTrials.gov Archive Site
Patient Satisfaction [ Time Frame: Base line and at18 months. ] [ Designated as safety issue: No ]
Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.
Not Provided
Not Provided
Not Provided
 
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Diabetes Telemedicine Consultation: A Systems Improvement Intervention

This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).

Background:

Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.

Objectives:

The objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the Primary Care Provider (PCP) and other relevant care team members. The impact of the 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.

Methods:

Study settings include the CBOCs affiliated with the Cleveland Veterans Affairs Medical Center (VAMC) and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N 282)=included: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c > 7.0%; or (iii) fasting glucose levels> 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Diabetes Mellitus Type 2
  • Diabetes Mellitus, Type 1
  • Primary Care Provider
  • Behavioral: The Diabetes Treatment Satisfaction Questionnaire
    A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
  • Behavioral: Diabetes Empowerment Scale
    A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
  • Behavioral: CBOC's undergo half-day joint-clinics via teleconference
    A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
  • Experimental: Telemedicine CBOC

    Designated CBOC's were involved in the intervention phase where their Diabetes Mellitus (DM) patients were asked to participate in a telemedicine visit.

    The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.

    Interventions:
    • Behavioral: The Diabetes Treatment Satisfaction Questionnaire
    • Behavioral: Diabetes Empowerment Scale
    • Behavioral: CBOC's undergo half-day joint-clinics via teleconference
  • No Intervention: Control CBOC
    The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
  • No Intervention: Provider Interviews
    Qualitative interviews with providers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
December 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1) Current prescription of insulin or an oral hypoglycemic agent
  • 2) A1c > 7.0%
  • 3) fasting glucose levels > 130 mg/dl
  • 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included

A Primary Care Provider for a Cleveland CBOC

Exclusion Criteria:

  • 1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months)
  • 2) documented dementia, aphasia, and psychosis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119041
IIR 03-254
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David C Aron, MD MS Louis Stokes VA Medical Center
Department of Veterans Affairs
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP